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Cited by 24Genetic and Clinical Aspects of Sex Determination and Chromosomal AbnormalitiesSexual Differentiation and DisordersHypothalamic control of reproductive hormones

Individualised vs fixed dose of oral 17β-oestradiol for induction of puberty in girls with Turner syndrome: an open-randomised parallel trial

Labarta, José I, Moreno, Maria L, López-Siguero, Juan P, Luzuriaga, Cristina, Rica, Itxaso, Sánchez-del Pozo, Jaime, Gracia-Bouthelier, Ricardo·2012·European Journal of Endocrinology
DOI 10.1530/eje-12-0444
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Abstract

CONTEXT: Oestrogen induction of pubertal changes in Turner girls may reinforce their psychological well-being and may also optimise final height; however, oestrogen type, dose, and route are not well established. OBJECTIVE: To induce normal pubertal development in Turner girls and ovarian insufficiency with oral 17β-oestradiol (E(2)), either as individualised dose (ID) or as fixed dose (FD), and to determine whether growth is affected. DESIGN: Open-label randomised, parallel groups, multicentre clinical trial in 48 GH-treated Turner girls. Oral E(2) was given in tablets, either as an ID of 5-15 μg/kg per day during 2 years or as a FD of 0.2 mg daily during the first year followed by 0.5 mg daily during the second year. Main outcome measures were the event of attaining a Tanner breast staging ≥4 (primary), FSH, and auxological variables (secondary). RESULTS: Shorter median time to Tanner staging ≥ B4 in the FD group (733 days) compared with the ID group (818 days) (P=0.046). Higher proportion of girls with Tanner staging ≥ B4 (65%) in the FD group compared with the ID group (42%) (P=0.068). Bone age did not show inadequate acceleration and adult height prediction was maintained in both groups. No oestrogen-related adverse events were reported. CONCLUSIONS: Two-year treatment with oral E(2) can progressively induce normal pubertal development in Turner syndrome. Low-dose oral E(2) given as a FD produces a satisfactory pubertal development not inferior to ID. Treatment was well tolerated and did not interfere with the growth-promoting effect of GH.

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Crossref · 10.1530/eje-12-0444

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Authors
Labarta, J. I., Moreno, M. L., López-Siguero, J. P., Luzuriaga, C., Rica, I., Sánchez-del Pozo, J., & Gracia-Bouthelier, R.
Affiliations
  • Hospital Universitario Miguel Servet (ES)
  • Novo Nordisk Pharma, SA (Spain) (ES)
  • Marqués de Valdecilla University Hospital (ES)
  • Hospital de Cruces (ES)
Corresponding author
Labarta, José I
ORCID
Venue
European Journal of Endocrinology
Publisher
Oxford University Press (OUP)
Published
2012-10
Volume
167
Issue
4
Pages
523-529
ISSN
  • 0804-4643 (ISSN-L)
  • 1479-683X
DOI
10.1530/eje-12-0444
OpenAlex
W2162369046
Cited by
24
References
36
Citations by year
2026: 1 · 2024: 1 · 2022: 8 · 2021: 3 · 2019: 2 · 2018: 1 · 2017: 3 · 2016: 1 · 2015: 2 · 2014: 1 · 2013: 1
FWCI
0.77
Type
journal article
Language
en
Open access
closed
Locations
  • European Journal of Endocrinology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetic and Clinical Aspects of Sex Determination and Chromosomal Abnormalities
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Sexual Differentiation and Disorders
  • Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
Keywords
Turner syndrome, puberty induction, fixed dose, ovarian insufficiency, breast development, adult height, growth hormone therapy, bone age, follicle-stimulating hormone
MeSH terms
Administration, Oral, Adolescent, Body Height, Child, Dose-Response Relationship, Drug, Estradiol, Female, Humans, Ovulation Induction, Puberty, Time Factors, Turner Syndrome, Adolescent Development, Precision Medicine

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